Health Law Advisor

As much of the Southeastern U.S. continues to recover from the aftermath of Hurricanes Helene and Milton, health care providers should be aware of, and consider the extent upon which they rely upon, the flexibilities that the Centers for Medicare & Medicaid Services (CMS) extended to assist with the Public Health Emergencies (PHEs) in the affected states. As a result of Hurricanes Helene and Milton, CMS extended additional resources to Medicare providers and certain health care facilities in Florida, Georgia, North Carolina, South Carolina, and Tennessee.

As background, during a PHE, the Secretary of the U.S. Department of Health and Human Services (HHS) may temporarily waive certain HIPAA Privacy Rule requirements for hospitals.

During the recent PHE, HHS issued HIPAA-related waivers lasting up to seventy-two (72) hours to hospitals located in the declared emergency that had activated their disaster protocol, including waivers for: the distribution of HIPAA privacy notices; patient rights to request privacy restrictions and confidential communications; communications with family or friends involved in care; and, opting out of facility directories. Health Information Privacy PHE responses can be found here.

In this episode of the Diagnosing Health Care Podcast: What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders?

At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies, yet no two states are exactly alike in their approach to defining and regulating telehealth.

On this episode ...

On October 18, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), which is tasked with enforcing the Health Insurance Portability and Accountability Act (“HIPAA”), issued two new guidance documents pertaining to privacy and security risks associated with the use of telehealth services. One guidance document, entitled “Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth,” is aimed at health care providers (the ...

This Diagnosing Health Care episode examines the fraud and abuse enforcement landscape in the telehealth space and considers ways telehealth providers can mitigate their enforcement risks as they move into the new year. Hear how the uptick in enforcement warrants close consideration by telehealth providers, especially those that are new to the space and have not yet built their compliance infrastructures.

The episode features Epstein Becker Green attorneys Amy Lerman, Melissa Jampol, and Bonnie Scott.

The Diagnosing Health Care podcast series examines the business ...

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.

Many manufacturers utilize their field sales representatives to deliver drug samples directly to, and collect written receipts from, prescribers at prescriber offices during sales calls. The COVID-19 crisis has disrupted field sales representatives’ ability to have face to face visits with prescribers, preventing them from delivering samples and collecting required receipts.  In addition, as a result of the crisis, many prescribers are providing telehealth services from their homes, impacting prescribers’ ability to receive, store and distribute samples at their offices.

On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period.[1] Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.[2]

Separate from and in addition to the blanket waivers, the Secretary’s authority under Section 1135 also allows CMS to grant Section 1135 waivers to states that request CMS to temporarily waive compliance with certain statutes and regulations for its Medicaid programs during the time of the public health emergency. So far, many states have requested these additional flexibilities in order to focus their resources on combatting the outbreak and providing the best possible care to Medicaid enrollees in their states. CMS has been rapidly approving these Section 1135 waiver requests, but it is important to recognize that not all state requests are created equal with respect to utilizing telehealth / telemedicine services during the public health emergency. Based on a review of the publicly available state request letters, it is clear that some states have prioritized use of telehealth in order to respond to COVID-19, while other states have not, or have not yet requested similar flexibilities related to provision of telehealth services. Examples of states that have prioritized greater use of telehealth include:

• California: The state requested flexibility for telehealth and virtual communications to make it easier for providers to care for people in their homes. Specifically, California requested flexibility to allow telehealth and virtual/telephonic communications for covered State plan benefits, such as behavioral health treatment services, and waiver of face-to-face encounter requirements for Federally Qualified Health Centers and Rural Health Clinics, among others. The state also sought reimbursement of virtual communication and e-consults for certain providers. CMS approved this waiver request on March 23, 2020.
• Illinois: The Illinois Department of Healthcare and Family Services waiver request, approved on March 23, 2020 by CMS, sought flexibility of documentation requirements, including the lack of documentation of consent for a telehealth consult. Like several other states, Illinois also requested CMS to allow providers to use non-HIPAA compliant telehealth modes from readily available platforms, such as Facetime, WhatsApp, Skype, etc., to facilitate a telehealth visit or check-in at the location of the patient, including the patient’s home.

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and consolidation in 2020.  These predictions for 2020 are largely based on the increasing confluence of the following three key “drivers” of health industry transformation that is substantially underway:

1. The ongoing national imperative of reducing the cost of health care, via disease prevention and detection, and cost-effective, quality treatment, including more efficient care in ambulatory and retail settings;
2. Extraordinary advances in technologies which enhance disease prevention, detection and cost-effective treatment (e.g., artificial intelligence (AI)-driven diagnosis and treatment, virtual care, electronic medical record (EMR) systems, medical devices, gene therapy, and precision medicine); and
3. The aging baby-boomer population, with tens of millions of Americans entering into their 70s, 80s, and above.

On September 10, 2019, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published Advisory Opinion 19-04.  In this favorable opinion, OIG approved a technology company’s proposal to make its online healthcare directory search results visible to federal healthcare beneficiaries in locations where the company charges the healthcare professionals a per-click or per-booking fee to be included in the directory.  It also approved the company’s proposal to make sponsored advertisements that appear on its online healthcare directory and ...

The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)) (the “Ryan Haight Act” or “Act”) expanded the federal Controlled Substances Act to define appropriate internet usage in the dispensing and prescribing of schedule drugs, and in doing so effectively banned the issuance of prescriptions via telemedicine services for any controlled substances unless the ordering physician has conducted at least one in-person evaluation of the patient. The Act includes multiple exceptions that permit prescribing of controlled substances ...

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited ...

At first blush, the passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), appears to address the issue concerning the lack of regulatory guidance regarding the “Special Registration” exception to the Ryan Haight Act of 2008; however, a deeper and more careful analysis reveals that the Bill may not be as effective as most health care practitioners may hope. The Bill, sponsored by Rep. Carter (R-Georgia), a pharmacist, Rep. Bustos (D-Illinois), and nine others, cleared the House on June 12, 2018 without ...

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently released a report revealing that during OIG’s 2014 and 2015 audits of telehealth claims, more than half of the professional telehealth claims paid by the Medicare program did not have matching originating-site facility claims.

According to the report, Medicare telehealth spending increased from $61,302 in 2001 to $17,601,996 in 2015. Among the 191,118 Medicare paid distant-site telehealth claims (totaling $13,795,384), the OIG randomly sampled 100 of those claims and obtained ...

On December 14, the Federal Communications Commission (FCC) voted to remove regulations that prohibit providers from blocking websites or charging for high quality service to access specific content. Many worry that allowing telecommunications companies to favor certain businesses will cause problems within the health care industry. Specifically, concerns have risen about the effect of the ruling on the progress of telemedicine and the role it plays in access to care. Experts worry that a tiered system in which service providers can charge more for speed connectivity can be ...

On October 26, 2017, President Trump directed the Secretary of the Department of Health and Human Services (“Secretary”) to declare a National Public Health Emergency on the opioid epidemic. While the President offered few details regarding how his administration will address the challenge of treating patients struggling with opioid addiction, a previous statement from the White House indicated that the Administration plans to expand access to treatment via telemedicine and more specifically, remote prescribing of the necessary controlled substances used to treat ...

Updates to OIG FY 2017 Work Plan

The United States Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) recently updated its FY 2017 Work Plan. Traditionally, OIG’s annual Work Plan has given health care providers a preview of OIG’s enforcement priorities. With the OIG now making updates to its Work Plan on a monthly basis, providers stand to gain even more insight into how the focus of OIG is constantly shifting in order to assist in the identification of significant compliance risk areas.

In this most recent set of updates to the FY 2017 ...

Telehealth continues to be a hot topic of state and federal legislatures. Texas, for example, recently joined the rest of the states in no longer requiring initial in-person visits before being able to provide telehealth services.

The Texas legislature enacted the major telehealth bill SB 1107 on May 19, 2017, and the governor signed the bill into law shortly thereafter on May 27, 2017. As reported in our prior post, Texas had considered that, if passed, this telehealth bill would allow patient-physician relationships to be established via telemedicine without requiring an initial ...

In recent years, Texas has served as ground zero for a number of the most contentious legal battles surrounding telehealth. This week, State Senator Charles Schwertner, the chairman of the Committee on Health and Human Services, submitted a bill signifying progress for telemedicine and telehealth providers looking to practice in the Lone Star State. The bill, S.B. 1107, would remove one of the toughest hurdles for telemedicine and telehealth practitioners – the face-to-face meeting requirement. Providers would be able to provide services to, and establish physician-patient ...

Telemedicine has made great recent strides in terms of greater acceptance and deployment.  That said, a lot of work still needs to be done. Two recent surveys, one of tech savvy consumers and another of health care stakeholders make that case.

The first survey was done on behalf of a consumer health engagement company.  It makes for sobering reading. The survey polled 500 insured consumers who are also users of mobile health applications.  Some interesting findings:

• Almost 40% have not heard of telemedicine.
• 42% who have not used telemedicine and prefer an in-person physician visit ...

As you all know, the subject of telehealth reimbursement continues to vex the community. For example, Medicare lags far behind.  According to the Center for Telehealth and eHealth Law, Medicare reimbursed approximately $14 million total under its telehealth benefit for 2014.  This represents less than .0025 percent of the total Medicare reimbursed for services that year.  Medicaid is something of a mixed bag with the vast majority of states providing some coverage for telehealth, but many lagging in coverage and reimbursement for store-and-forward services and remote patient ...

As 2015 winds down, I think it is safe to say that it has been a whirlwind year in telehealth.  According to the National Conference of State Legislatures (NCSL), over 200 telehealth-related bills were introduced in 42 states.  The Federation of State Medical Boards (FSMB) has launched an interstate physician licensure compact that creates a new pathway to expedite physician licensure in multiple states.  Twelve states (with Wisconsin being the latest) have so far enacted the licensure compact.  Many states such as Colorado, Iowa, and Louisiana released regulations or policies that in ...

One of the issues with which we often grapple in the telehealth space is the relative lack of availability of studies and data when compared to other areas of the health care sector.  Telehealth is relatively young and therefore has not had the time to build a voluminous body of data and evidence.  But things are changing.  Many stakeholders are doing exemplary work in telehealth research, and stakeholders like the Department of Veterans Affairs have longstanding evidence regarding the efficacy of telehealth.  However, it’s a more recent document that has caught my attention.

A ...

A recent survey conducted by the Robert Graham Center, the American Academy of Family Physicians, and Anthem caught my attention. The survey was conducted to gauge the attitudes of primary care physicians regarding telehealth.  And the results make for interesting reading— providing great insight into how certain providers view and use telehealth. What struck me most is that while great progress has been made in the rate of telehealth adoption among providers, we still have a way to go. According to the survey report, state legal and regulatory issues, reimbursement, and provider ...

Telemental health seems to be emerging, even booming.  Also referred to as telebehaviorial health, e-counseling, e-therapy, online therapy, cybercounseling, or online counseling, for purposes of this post, I will define telemental health as the provision of remote mental health care services (usually via an audio/video secure platform) by psychiatrists, psychologists, social workers, counselors, and marriage and family therapists.  Most services involve assessment, therapy, and/or diagnosis.   Over the last few years, I have seen a wider variety of care models—from ...

As many of you know, reimbursement for telehealth services is a mixed bag.  On the one hand, private payers generally seem ahead of the curve.  Many leading private insurers reimburse for telehealth.  Generally these coverage policies provide reimbursement for telehealth services when they involve the use of real-time interactive audio, video, or other electronic media for diagnosis and consultation.  Just as significantly, more than half the states and the District of Columbia have passed telehealth parity statutes which require health insurers to provide coverage for services ...

As stakeholders, legislators and policymakers wrestle with the myriad of issues related to the provision of remote health care, clinical and technological advancements continue apace. What was once an industry focused primarily on the provision of primary care through existing remote platforms is morphing into a highly sophisticated brew of clinical and technological innovation.  In that regard, several trends have caught my attention. While these trends may not squarely fall within the accepted definitions of “telehealth”, they are worth noting because they raise many ...

As telehealth legal and regulatory issues continue to evolve, stakeholders need to stay current on trending issues. With that in mind, we are offering a complimentary “crash course” webinar series in which we will discuss a number of significant legal and regulatory issues implicated by telehealth including reimbursement, state issues, and employers.

How Do I Get Paid?

During this first installment of EBG’s Telehealth Crash Course series, we will discuss the current reimbursement landscape, including distinctions between various payer models and the growing impact of ...

As discussed previously on this blog, employers are increasingly turning to telemedicine as a way to cut employee health care costs and improve bottom lines. The trend will be accelerated by the impending Cadillac Tax, a 40 percent excise tax on the excess of the cost of an employee’s applicable coverage over the employee’s applicable dollar limit. In February, the Treasury and IRS released Notice 2015-16 (the “Notice”), kicking off the process of developing regulatory guidance regarding the Cadillac Tax. Specifically, the Notice addresses the following issues:

I have examined on this blog the various legal and regulatory issues implicated by telemedicine.  Many of those issues involve the practice of medicine and how state medical boards interpret state laws and regulations impacting telemedicine, and how those boards enforce those laws.  Believe it or not, a recent Supreme Court case may have an impact on how state boards do their business.

On February 25, 2015, the Supreme Court of the United States held that the North Carolina Dental Board (“Board”) was not insulated from federal antitrust liability under the so-called “state ...

As we have explored a number of times on this blog, telemedicine has gone mainstream.  The more recent development is that employers seem to be paying more attention now. The numbers speak for themselves. A recent Towers Watson study focusing on employers with at least 1,000 employees concluded that U.S. employers could save up to $6 billion per year if their employees routinely engaged in remote consults for appropriate medical problems instead of visiting emergency rooms, urgent care centers, and physicians’ offices.

Attitudes towards telemedicine more generally in the United ...

As a lawyer practicing in the telemedicine space, I am rarely surprised these days.  But every once in a while I will read or hear something that stops me in my tracks. That is exactly what happened when I read a blog post by an FTC Commissioner which, among other things, calls for government policies that help facilitate greater adoption of telemedicine.  The post was part of a broader piece about the FTC's role in promoting competition and innovation in health care.

By way of quick background, the Federal Trade Commission is the federal agency charged with protecting ...

Earlier this week, the American Telemedicine Association reported an important clarification regarding the Centers for Medicare & Medicaid Services’ (“CMS’s”) plans for expanding reimbursement for telehealth services provided to Medicare beneficiaries.  The October 31, 2014 final rule with comment period regarding payments to physicians generated much excitement in the telehealth community, particularly because it opens a door, albeit only slightly, to possible Medicare coverage for remote patient monitoring services.

However, the ATA has clarified with CMS ...

Who knew?!  Buried among more than 1,000 pages of a new final rule with comment period on payments to physicians, released on October 31, 2014, the Centers for Medicare & Medicaid Services (“CMS”) finally has given telehealth providers a glimpse of its plans to expand reimbursement for telehealth services provided to Medicare beneficiaries. 

The final rule includes a provision that would cover remote chronic care management using a new current procedural terminology (“CPT”) code, 99490 (with a monthly unadjusted, non-facility fee of $42.60).  This new CPT code can be ...

There can be no question that telehealth has gone mainstream.  The numbers speak volumes. Telehealth companies have been able to raise almost $500 million since 2007 according to a noted venture capital analyst.  A recent study indicated that U.S. employers could save up to $6 billion a year through telehealth.  Per the American Telemedicine Association, more than half of all U.S. hospitals now offer some form of telehealth service.  Some leading analysts estimate that global revenue for telehealth will reach $4.5 billion by 2018, and the number of patients using telehealth services ...

About a month ago, I had the opportunity to participate at the Inaugural Advances in Clinical Technology conference in London.  The conference covered a broad array of topics relating to how technology can and is changing how clinical trials are conducted.  Here are the top three things that I took away from the conference.

1. The upsides of the e-patient far outweigh the downsides 

Earlier this year, the Wall Street Journal published an article highlighting one of the biggest downsides of the e-patient, their use of electronic communication tools to learn more about their condition ...

A significant barrier to the interstate practice of telehealth is closer to being broken down. The Federation of State Medical Boards (FSMB) has completed and distributed a draft Interstate Medical Licensure Compact, designed to facilitate physician licensure portability that should enhance the practice of interstate telehealth.  Essentially, the compact would create an additional licensing pathway, through which physicians would be able to obtain expedited licensure in participating states.  As the FSMB notes in its draft, the compact "complements the existing ...

By:  Alaap Shah and Ali Lakhani

The Good: 

“Hey Doc, just shoot me a text . . .”

The business case supporting text messaging in a health care environment is compelling - it is mobile, fast, direct, and increases dialogue between physicians and patients as well as streamlines the often inefficient page/callback paradigm that stalls workflows and efficiency in the supply chain of healthcare delivery.  As a growing percentage of the 171 billion monthly text messages in the U.S. are sent by healthcare providers, often containing electronic protected health information (ePHI ...

Below is a re-print of an article that we recently wrote for the Advisory Board Company’s 2013 third quarter General Counsel Agenda. To view the original publication in the General Counsel Agenda, click here.

For hospitals, the promise of telehealth has spurred innovation across multiple service lines and led to the emergence of a number of new delivery models such as telestroke, teleradiology, telepsychiatry, telepathology, teleICU and remote patient monitoring.  While many of these programs are leading to significant improvements in access to health care services, quality ...

Telehealth creates unique health information management challenges for various reasons, including: aggregating large data sets (i.e. remote monitoring); using and storing numerous file formats (video, audio, text, digital images, film); establishing safeguards for sharing data with virtual providers and distant sites; determining the appropriate location for data storage (if more than one provider or entity is involved); and more.  All of these challenges create issues relating to medical record management, maintenance, ownership, and storage.

In the past, it was easier ...

Christine Kearsley contributed to this article.

In Durham, North Carolina, the child psychiatrist comes to the classroom.  By telehealth. For the past eight years, Duke University Medical Center has teamed up with Durham Public Schools to export child psychiatry to where the kids are.  Duke fellows in child psychiatry travel to three elementary schools and one upper-school site to offer in-person mental health services to children with diagnosed mental health disorders.  To supervise the fellows, the attending physician conferences in.  As Dr. Richard D’Alli, the leader of the ...

About two weeks ago, the Governor of Nevada signed into law new legislation that removes a number of barriers to the practice of telehealth within the state of Nevada.  Among the most significant changes, the Nevada legislation allows physicians to establish a physician-patient relationship (which is a precondition for prescribing drugs, rendering diagnoses, and performing other medical services) through a telehealth encounter.  In doing so, Nevada joins only a small number of states that have taken this step.  However the Nevada law is significant not only because it allows a ...

Before initiating treatment, health care providers must generally obtain their patients’ informed consent. The purpose of the informed consent process is two-fold. First, it allows patients to gain an understanding of the risks and benefits of the proposed treatment, and alternative courses of action. Second, it helps shield providers from legal exposure.

A formal informed consent process is particularly critical for procedures that carry a high risk of patient injury. When considering such “high-risk” procedures, neurosurgery or radiation therapy may come to mind ...

In the healthcare industry we often associate information privacy and security enforcement with HIPAA and state privacy laws.  However, a lesser known but in some cases just as significant regulator of information privacy is the Federal Trade Commission (“FTC”). This is especially true with regard to mobile health applications, which depending on how they function and collect personal information, may not be regulated by HIPAA.  Regardless of whether or not you have to comply with HIPAA, if you run applications or software that can access personal information, then the FTC’s ...

While telehealth technology advances, unresolved legal issues continue to deter wider adoption of telehealth as a means of delivering health care services. One issue that telehealth providers must consider is the standard of care that applies in telehealth encounters. Generally, a plaintiff in a medical malpractice suit must prove, among other things, that the provider breached the standard of care. Therefore, knowing what standard of care applies is critical for any telehealth provider that wishes to insulate itself from potential malpractice liability.

In traditional ...

Telehealth is going mainstream. Once limited to rural or remote communities, the use of telehealth is increasingly being used to address critical shortages within many medical specialties (such as dermatology, neurology, radiology, critical care and mental health), and as a more efficient means to provide health care services. Many leading nationally-recognized health care providers, health plans and others have significant telehealth initiatives underway often in partnership with telecommunications vendors and government entities.  And developments in this space tend ...

As the technologies used to deliver telehealth services become more complex, telehealth providers as well as other HIPAA “covered entities” have an increasingly demanding role to play in ensuring the security of protected health information (PHI).  To fulfill this role, both telehealth providers and their business associates (such as the information technology companies and data storage providers that support telehealth platforms) must implement not only technical safeguards, but also physical security measures.  From locks, to security guards, to alarm systems ...

Too often, companies try to re-invent the wheel.  This is especially true in the telehealth sector where new models of care are constantly being tried and tested.  Fortunately for U.S. hospitals, health systems, and companies, however, we have great examples of telehealth models from around the world that have built successful business models in telehealth.

Take the example of Calydial, a company based in Lyon, France, that specializes in remote dialysis. Launched in 2006, Calydial started with 25 patients with renal impairment who needed remote treatment and monitoring. Today ...

Telehealth is expanding rapidly outside of the U.S. in both developed and developing countries.  Not surprisingly, the expanded use of telehealth presents many of the same regulatory and reimbursement challenges abroad that it does here in the U.S.  One region in particular that has taken steps to expand telehealth across borders is Europe, where in an effort to confront the legal issues raised by telehealth, the E.U. has removed and revisited existing regulations.  The E.U. has also issued guidance through the European Commission (an institution that is responsible for ensuring ...

When evaluating the various legal and regulatory hurdles associated with telehealth—such as licensure, reimbursement, and privacy—one hurdle that often goes overlooked is the corporate practice of medicine.  Many states have enacted laws which directly or indirectly are viewed as prohibiting the “corporate practice” of medicine.  While variations exist among states, the doctrine generally forbids a person or entity, such as a general business corporation, other than a licensed physician, professional corporation (“PC”) or a professional limited liability ...

The rapid development and utilization of remote patient monitoring tools in health care exposes the limitations of state licensure laws that generally require physicians to be licensed in states where their patients are located.  These laws are predicated on the physician and patient being in the same jurisdiction.  However, when using mobile-devices to actively monitor patients (such as a device sensor with 4G chipset that can directly connect to cellular networks), there is no single geographic anchor or fixed moment in time from which to define the encounter, episode or point of ...

While tech companies looking to provide health solutions must figure out early on whether they are HIPAA-regulated, HIPAA is not the be-all and end-all of privacy law. Even entities not regulated under HIPAA must abide by other privacy rules, including a wide array of state privacy laws. On December 6, 2012, in the state’s first legal action under its online privacy law, California Attorney General Kamala Harris filed a lawsuit against a major airline for not including a privacy policy in its smartphone app. The complaint alleges violation of California’s Online Privacy ...

While tremendous strides continue to be made in the growth and adoption of telehealth services, significant legal obstacles remain.  Among these obstacles are state drug prescribing laws.  In many states, physicians cannot lawfully prescribe drugs during a telehealth encounter, except in very limited circumstances.  For example, California requires that physicians perform a “physical exam” before prescribing drugs, and explicitly outlaws prescribing on “the internet” without a prior examination.  These restrictions vary from state to state, but many share certain ...

by Joel Rush and Dawn Helak

All indications are that international telemedicine is well positioned for strong growth over the next several years. The global healthcare marketplace is ripe with opportunities for U.S. based healthcare systems and providers to take advantage of the expanding use of telemonitoring systems and other telemedicine technologies to deliver top flight healthcare to patients across the globe.

However, wherever there are opportunities, there are challenges. In addition to the economic and financial barriers to launching an international telemedicine ...

Imagine there are two hospitals (or two physician groups). One is highly specialized and has developed a telemedicine program for treating stroke patients; the other is a community hospital or physician practice that would like to take part in this telemedicine program but does not want to pay for the technology needed to virtually connect with the program’s specialists. Can the telemedicine provider buy this technology for the receiving hospital or physician group, or rent it out at a deep discount, without violating the law?

This turns out to be a hard question. Under federal law ...

In the past few months, we’ve seen a number of federal agencies take important steps to promote telemedicine. In May, the Department of Agriculture began a $15 million grant and loan program that will provide funding to innovative rural telemedicine programs; the Veteran’s Administration, building on its already impressive telemedicine capabilities, reported in July that it will be testing a new telemedicine system designed to support rural primary care providers; and in May and June the Centers for Medicare and Medicaid Services Center for Innovation awarded funding to a ...

Many legal obstacles have long stood in the way of telehealth. There are licensure laws, prescribing laws, practice of medicine requirements, credentialing rules, insurance coverage issues, and concerns about privacy, among others.  These hurdles have until recently relegated telehealth to the most geographically remote corners of health care where the only means of obtaining medical care is by phone or computer connection to a provider hundreds of miles away.  But now, with physician shortages and the ubiquity of the smart phone, telehealth is beginning to show up all over the ...

There is a proposal moving through Congress that has some interesting implications for telemedicine.  Sen. Diane Feinstein (D-CA) and Rep. Bill Cassidy (R-LA) have proposed an amendment to the Online Pharmacy Safety Act that would impose additional restrictions on when and under what circumstances practitioners can prescribe medication under the Federal Food, Drug, and Cosmetic Act.  Although the Online Pharmacy Act is primarily intended to put an end to illegitimate pharmacies and the fraudulent sale of drugs online, as the American Telemedicine Association, HealthLeaders

Perhaps in recognition of its benefits to areas affected by shortfalls in specialists and primary care physicians or the need for remote monitoring, telemedicine received significant funding in the ARRA. For instance, the Rural Utilities Service was allocated $2.5 billion to fund “shovel-ready” distance learning, telemedicine, and broadband program; the Indian Health Services received $85 million to fund telemedicine; and a portion of the $2 billion allocated to the Office of the National Coordinator is to be used to support the “infrastructure and tools for the ...